1958

Isolated Hepatic Perfusion (IHP) was the first procedure to validate the benefits of liver-directed, high-dose chemotherapy, with greatly reduced systemic drug exposure.

1982

Delcath performs the first whole-organ, liver-directed procedure using Percutaneous Hepatic Perfusion (PHP)

2003

A Phase 1 trial was conducted by the National Cancer Institute (NCI) using Delcath’s PHP® technology. Results showed that 60% of evaluable people treated with high-dose chemotherapy directly to the liver experienced anti-tumor activity, with over half achieving tumor shrinkage greater than 50%

2008

FDA grants Delcath orphan drug designations of Melphalan HCl for treatment of cutaneous melanoma and ocular melanoma

2009

FDA grants Delcath orphan drug designation of Melphalan HCl for treatment of neuroendocrine tumors

2010

A randomized Phase 3 clinical trial of patients with ocular and cutaneous melanoma liver metastases achieves primary endpoint of extended hepatic progression-free survival (hPFS) utilizing prior version of medical device.

A multi-cohort Phase 2 trial shows that in patients with neuroendocrine metastases to the liver (n=24) an objective tumor response rate of 42% was achieved and 66% of patients experienced hepatic tumor shrinkage and disease stabilization.

2012

NDA accepted for review by the FDA for Melphalan/HDS

CE mark received, treatment regulated as a Class III medical device. Later reclassified to class IIb.

Delcath introduces the Generation Two version of the CHEMOSAT system, which offered improved hemofiltration efficiency and other product enhancements

2013

NDA rejected by the FDA; Complete Response Letter issued. Delcath undertakes a number of procedural refinements, including modifications to the pre, peri and post procedure patient management and monitoring.

FDA grants Delcath orphan drug designation of Melphalan HCl for treatment of hepatocellular carcinoma (HCC)

Commercialization efforts begin in Germany & UK

2015

FDA grants Delcath orphan drug designation of Melphalan HCl for treatment of intrahepatic cholangiocarcinoma (a form of bile duct cancer)

National reimbursement coverage for CHEMOSAT awarded in Germany

Delcath activates a prospective patient registry to collect uniform essential patient safety, efficacy, and quality of life data from treatments performed by cancer centers in Germany, the United Kingdom, and the Netherlands.

2016

Delcath initiates FOCUS, a new, pivotal Phase 3 overall survival (OS) clinical trial for patients with ocular melanoma metastatic to the liver

Researchers at University Hospital Southampton presented at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany concluded that “PHP can be used safely by an experienced team to deliver liver-directed therapy in selected uveal melanoma patients, achieving unprecedented progression free and overall survival”.

2017

Dutch health authorities added CHEMOSAT to their treatment guidelines for patients with ocular melanoma metastatic to the liver

Two European centers, one in Southampton, England and one in Hannover, Germany celebrate the completion of over 100 treatments

2018

FOCUS Trial amended to multi-center single arm Registration trial. Primary endpoint Objective Response Rate (ORR) after consultation with the Food and Drug Administration (FDA)

German health authorities added CHEMOSAT to the German Melanoma S3-Guidelines, providing a level 1B evidence rating for patients with ocular melanoma metastatic to the liver

Delcath celebrates over 700 patients treated worldwide, both in the clinical & commercial setting